Introduction: CMS and AAOS have questioned the effectiveness of hyaluronic acid in the treatment of knee OA either in the CMS population[1], or on a general basis[2]. However, alternative therapies such as allograft amniotic tissues have a long history of clinical use[3]. Amniotic fluid is a homologue to synovial fluid: both cushion, protect and lubricate the contents of a closed environment. Summary of methods: This is a protocol-driven, single arm postmarket Registry run under the guidance of Western Institutional Review Board (Olympia, WA). Enrollees were diagnosed with Grade 1-3 OA. Exclusion criteria entailed those who received HA injections in the previous six months, or steroid or PRP injection in the last three months. Primary endpoints are pain VAS and WOMAC at baseline and at 30, 90 and 180 days. Results: This is an interim report of the first 170 patients saw increase in WOMAC and VAS scores. An increase of an average of 70.9 percent (812mm) and 68.1 percent (44mm), respectively at 30 days and at 90 days total WOMAC and VAS average improvements increased to 82 percent and 74 percent, respectively. Conclusions: In this Registry, early outcomes suggest that the use of a processed amniotic fluid allograft (AmnioClear LCT; Liventa Bioscience, West Conshohocken, PA) may offer a safe and highly effective alternative in the treatment of knee OA. More and longer term data will be offered in coming months. This Registry is being underwritten by Liventa Bioscience (West Conshohocken, PA)
This Registry is being underwritten by Liventa Bioscience (West Conshohocken, PA). References: 1) AHRQ Technology Assessment; 11/26/14; Systematic Review for Effectiveness of Hyaluronic Acid in the Treatment of Severe Degenerative Joint Disease (DJD) of the Knee. 2) OARSI guidelines for the non-surgical management of knee osteoarthritis; Osteoarthritis Research Society International, May 2013. 3) Trelford JD, Trelford-Sauder M; The amnion in surgery, past and present. Am J Obstet Gynecol. 1979 Aug 1;134(7):833-45. 4) Shimberg, M; The Use of Amniotic Fluid Concentrate in Orthopedic Conditions; J Bone Joint Surg Am. 1938;20:167-177.